NDAINTRAVENOUSPOWDERPriority Review
Approved
May 2014
Lifecycle
LOE Approaching
Competitive Pressure
15/100
Clinical Trials
16
Data completeness
6/8 — Strong
Priority Review
DALVANCE (dalbavancin) by AbbVie is [see microbiology ( )] . First approved in 2014.
Drug data last refreshed 14h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
DALVANCE (dalbavancin) is a long-acting lipoglycopeptide antibiotic administered intravenously as a powder for reconstitution. It is indicated for acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive organisms. The drug inhibits bacterial cell wall synthesis through binding to D-Ala-D-Ala peptidoglycan precursors, with a half-life enabling once-weekly dosing.
$14MPart D
LOE Approaching1.9 years to LOEWith loss of exclusivity imminent in 2028, the brand is in defensive mode and the commercial team is likely focused on maximizing remaining years rather than growth initiatives.
Mechanism of Action
[see Microbiology ( )] .
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Dalbavancin Real-life Utilization in Diabetic Patients Suffering From Infections (DALBADIA)
Started Jan 2022
98 enrolled
DiabetesInfection
Substance Use Disorder (SUD)-Associated Infections' Treatment With Dalbavancin ENabling OUtpatient Transition
Started Apr 2021
11 enrolled
Gram-Positive Bacterial InfectionsGram-Positive BacteraemiaSubstance Use Disorders+1 more
DOTS: Dalbavancin as an Option for Treatment of Staphylococcus Aureus Bacteremia
Started Apr 2021
200 enrolled
Staphylococcal Bacteraemia
Evaluation of Intravenous Dalbavancin for Peritonitis
Started Jun 2020
2 enrolled
PeritonitisPeritonitis Bacterial
Safety and Efficacy of Dalbavancin Versus Active Comparator in Adult Patients With Osteomyelitis
Started May 2017
1 enrolled
Osteomyelitis
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.